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Clinic Roundup

• Acadia Pharmaceuticals Inc., of San Diego, and partner Biovail Corp., of Toronto, said that despite the recent failure of the Phase III 012 study of pimavanserin in Parkinson's disease psychosis, they remain committed to developing the drug in that indication and plan a third PDP study. The companies said they also plan to pursue adjunctive therapy with pimavanserin for schizophrenia as a third indication in the collaboration. The second ongoing PDP Phase III trial, known as 014, is testing 10-mg and 20-mg doses of pimavanserin. Biovail will be responsible for the cost of the third PDP Phase III trial, which is expected to start in the first half of 2010. Acadia said it would continue its ongoing open-label safety extension studies in patients with PDP. (See BioWorld Today, Sept. 2, 2009.)

• Helix BioPharma Corp., of Aurora, Ontario, said a pre-investigational new drug application meeting with the FDA confirmed the company's expectations for proceeding with two clinical programs. The firm completed a Phase II trial of topical interferon alpha-2b in cervical dysplasia and is seeking to start Phase II/III testing in the U.S. Helix also is seeking to enter Phase I testing of L-DOS47.

• Immutep SA, of Orsay, France, said interim results of its ongoing Phase I/II chemoimmunotherapy trial in metastatic breast carcinoma confirmed the clinical response rate of 50 percent with IMP321 associated with paclitaxel, compared to 25 percent with paclitaxel alone. IMP321 is an immunopotentiator designed to agonize MHC Class II molecules to stimulate antigen-presenting cells. The interim data are based on tumor regression under RECIST criteria in the first three cohorts of 24 patients compared to a historical control group of weekly paclitaxel.

• Merz Pharmaceuticals GmbH, of Frankfurt, Germany, reported data from a Phase III study showing that its NT 201 (botulinum toxin Type A free from complexing proteins), also known as Xeomin, was statistically significantly more efficacious than placebo in treating patients with post-stroke upper limb spasticity. In the intent-to-treat analysis among 148 patients, a larger proportion of patients (mean 63.9 percent) were rated as responsive in each of the treatment muscle groups at week four, compared with patients on placebo (mean 35.72 percent). Data showed that a higher proportion of patients receiving NT 201 were responders in terms of improvement in the wrist flexors four weeks after treatment. Responders were defined as patients with at least 1 point of improvement in the Ashworth Scale Score.

• Transdel Pharmaceuticals Inc., of La Jolla, Calif., reported positive top-line data from a Phase III trial of Ketotransdel, a topical formulation of nonsteroidal anti-inflammatory drug ketoprofen, showing that the study achieved statistical significance in the primary endpoint in the per protocol analysis of 252 patients. The primary endpoint was the difference between Ketotransdel and placebo in the change from baseline in pain intensity, as measured by the 100 mm Visual Analogue Scale during daily activities over the past 24 hours on day three. Patients enrolled in the study had acute soft-tissue injuries. Analysis of the intent-to-treat population, which included all study patients even if they failed to comply with protocol requirements, favored Ketotransdel over placebo but not to a degree that reached statistical significance. Ketotransdel also showed a safety and tolerability profile similar to placebo, and there were no treatment-related gastrointestinal, cardiovascular or other clinically relevant adverse events commonly observed with oral NSAIDs reported in the trial. Transdel is seeking a commercial partner for the product.

• Vantia Therapeutics, of Southampton, UK, said its oral small-molecule drug, VA111913, entered Phase II proof-of-concept trials in dysmenorrhea, or painful menstruation. Phase I results showed that VA111913 was safe and well tolerated. The multicenter, double-blind, placebo-controlled Phase II trial, which is being conducted in the UK and the U.S., plans to recruit 128 women, ages 18 to 35, with primary dysmenorrhea, including a consistent history of menstrual pain limiting daily activity and requiring medication for relief.